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Guidance and manufacturer’s declaration - electromagnetic emissions

OMRON BPM including AC-adapter is intended for use in the electromagnetic environment specified

below. The customer or the user of this OMRON BPM including AC-adapter should assure that it is

used in such environment.

Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions

CISPR 11

Group 1

The OMRON BPM including AC-adapter uses RF energy

only for its internal function. Therefore, its RF emissions

are very low and are not likely to cause any interference

in nearby electronic equipment.

RF emissions

CISPR 11

Class B

The OMRON BPM including AC-adapter is suitable for

use in all establishments, including domestic

establishments and those directly connected to the

public low-voltage power supply network that supplies

buildings used for domestic purposes.

Harmonic emissions

IEC 61000-3-2

Class A

Voltage fluctuations/

flicker emissions

IEC61000-3-3

Complies

Содержание HEM-9200T

Страница 1: ...INSTRUCTION MANUAL Blood Pressure Monitor Model HEM 9200T 5130713 0C ENGLISH ...

Страница 2: ... Information 5 1 Know Your Device 8 2 Preparation 12 3 Using the Device 15 4 Error Messages and Troubleshooting 22 5 Maintenance and Storage 27 6 Specifications 30 7 FCC IC Statement and Trademarks 32 8 Limited Warranty 34 9 Guidance and Manufacturer s Declaration 35 ...

Страница 3: ...tion manual thoroughly before using the device Please keep for future reference For specific information about your own blood pressure CONSULT YOUR PHYSICIAN Symbols Glossary For symbol information visit OmronHealthcare com symbols glossary ...

Страница 4: ... is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings ...

Страница 5: ...s poor perfusion diabetes age pregnancy pre eclampsia renal diseases Note that PATIENT motion trembling shivering may affect the measurement reading Do not use the device on the injured arm or the arm under medical treatment Do not apply the arm cuff on the arm while being on an intravenous drip or blood transfusion Consult your physician before using the device on the arm with an arterio venous A...

Страница 6: ...property General Usage Always consult your physician Self diagnosis of measurement results and self treatment are dangerous Consult your physician before using the device for any of the following conditions If you have had a mastectomy People with severe blood flow problems or blood disorders as cuff inflation can cause bruising Do not take measurements more than necessary It may cause bruising du...

Страница 7: ...es with their polarities incorrectly aligned Use only 4 AA alkaline or manganese batteries with this device Do not use other types of batteries Do not use new and used batteries together Remove the batteries if the device will not be used for three months or more General Precautions Do not forcibly crease the arm cuff or the air tube excessively Do not press the air tube while taking a measurement...

Страница 8: ...A batteries instruction manual quick start guide Monitor Arm cuff Arm circumference 9 17 22 42 cm A Display B START STOP button C Battery compartment D Air jack E AC adapter jack for optional AC adapter C D E A B F H G F Arm cuff G Air plug H Air tube ...

Страница 9: ...K symbol L Systolic blood pressure M Diastolic blood pressure N Battery symbol low depleted O Heartbeat symbol Flashes during measurement P Movement error symbol Q Irregular heartbeat symbol R Deflation symbol S Pulse display L M N L O K Q P R S I J ...

Страница 10: ...ol displays with your measurement results we recommend you consult your physician Follow the directions of your physician Movement Error Symbol The movement error symbol is displayed if you move your body during the measurement Please remove the arm cuff and wait 2 3 minutes Take another measurement remain still during measurement SYNC Symbol The SYNC symbol is displayed if device is not connected...

Страница 11: ...ers and is not guaranteed to connect to all Bluetooth Smart compatible devices and Telehealth service receiver Omron Healthcare Inc shall not be liable for loss of use or any other special incidental consequential or indirect costs expenses or damages due to improper usage of this monitor 1 3 Before Taking a Measurement To help ensure an accurate reading follow these directions 1 Avoid bathing dri...

Страница 12: ...attery symbol appears on the display turn the monitor off then replace all batteries at the same time Long life alkaline batteries are recommended The measurement values continue to be stored in memory even after the batteries are replaced The supplied batteries may have a shorter life Dispose of the device components and optional accessories according to applicable local regulations Unlawful disp...

Страница 13: ...lay shown above is not appeared see Connecting failure in section 4 2 first To retry connecting the Telehealth service receiver remove batteries and press START STOP button for 2 3 times Then start with step 2 again Note If your Telehealth service receiver asks for PIN code enter 6 digits of PIN code on the rating label at the bottom of the device to complete ...

Страница 14: ...pear on the display as below When Err appears see Connecting failure in section 4 2 for more detail Notes We recommend to keep batteries all the time even if you chose to use AC adapter If only AC adapter is used without keeping batteries above device connection process step 4 and 5 is necessary each time you unplug and plug back the AC adapter ...

Страница 15: ...5 3 Using the Device 3 1 Applying the Arm Cuff Remove tight fitting clothing or tight rolled up sleeve from your left upper arm Don t place the arm cuff over thick clothes 1 Connect cuff plug to the unit ...

Страница 16: ...rm cuff firmly in place around your left upper arm The bottom edge of the arm cuff should be 1 2 inch 1 to 2 cm above the elbow Air tube is on the inside of your arm and aligned with your middle finger 1 2 inch 1 2 cm ...

Страница 17: ...ful not to rest your arm on the air tube The blood pressure can differ between the right arm and the left arm and the measured blood pressure values can be different OMRON recommends to always use the same arm for measurement If the values between both arms differ substantially please check with your physician which arm to use for your measurements ...

Страница 18: ...feet flat on the floor Sit upright with your back straight Sit with your back and arm being supported The arm cuff should be placed on your arm at the same level as your heart 3 3 Taking a Measurement Notes To stop the measurement press the START STOP button once to deflate the arm cuff Remain still and do not talk while taking a measurement The memory cannot view on the display ...

Страница 19: ...c pressure is more than 210 mmHg After the arm cuff starts to inflate press and hold the START STOP button until the monitor inflates 30 to 40 mmHg higher than your expected systolic pressure Notes The monitor will not inflate above 299 mmHg Inflating to a higher pressure than necessary may result in bruising where the arm cuff is applied ...

Страница 20: ...red see Data is not being transmitted in section 4 2 for more detail 3 After data transfer is completed press the START STOP button to turn the monitor off It will automatically turn off after 2 minutes Note Wait 2 3 minutes before taking another measurement Waiting between measurements allows the arteries to return to the condition prior to taking a measurement ...

Страница 21: ...by your physician Only a physician is qualified to diagnose and treat High Blood Pressure This device is not intended to be a diagnostic device Always consult your physician Self diagnosis of measurement results and self treatment are dangerous Inflating to a higher pressure than necessary may result in bruising where the arm cuff is applied ...

Страница 22: ...ror continues to appear contact your physician Movement during measurement Carefully read and repeat the steps in section 3 3 Connecting failure Data is not being transmitted Refer Connecting failure Data is not being transmitted in section 4 2 The batteries are low Recommend to replace the batteries with new ones ahead of time Refer to section 2 The batteries are depleted Replace 4 batteries with...

Страница 23: ...asurement Remain still and do not talk during measurement Refer to section 3 3 If E2 appears repeatedly inflate the arm cuff manually until it is 30 to 40 mmHg above your previous measurement result Refer to section 3 3 The arm cuff was inflated exceeding the maximum allowable pressure and then deflated automatically when inflating the arm cuff manually Do not touch the arm cuff and or bend the ai...

Страница 24: ... still and do not talk during measurement Refer to section 3 3 Clothing is interfering with the arm cuff Remove any clothing interfering with the arm cuff Refer to section 3 1 Device error Contact your Telehealth service provider Error Display Cause Solution ...

Страница 25: ...new ones Check the battery installation for proper placement of the battery polarities Refer to section 2 Measurement values appear too high or too low Blood pressure varies constantly Many factors including stress time of day and how you wrap the cuff may affect your blood pressure Review the section 1 3 and section 3 3 ...

Страница 26: ... try again The Bluetooth feature on the receiver is turned off Turn the Bluetooth feature on the receiver ON and try to transmit the readings again The blood pressure monitor did not pair successfully to the receiver Try to pair the devices again Refer to section 2 The application on the receiver or destination device is not ready Check the application then try to transmit the readings again Refer...

Страница 27: ...atile cleaners Do not wash the device and any components by immersing them in water Do not use gasoline thinners or similar solvents to clean the device Use a soft dry cloth or a soft cloth moistened with neutral soap to clean on the monitor and the arm cuff Changes or modification not approved by the manufacturer will void the user warranty Do not disassemble or attempt to repair the device or co...

Страница 28: ...Note Do not bend or crease the air tube excessively Do not store the device in the following situations If the device is wet Locations exposed to extreme temperatures humidity direct sunlight dust or corrosive vapors such as bleach Locations exposed to vibrations shocks or where it will be at an angle ...

Страница 29: ... adapter into an electrical outlet To disconnect the AC adapter unplug the AC adapter from the electrical outlet first and then remove the AC adapter plug from the monitor Arm cuff AC Adapter Arm circumference 9 17 22 42 cm Arm circumference 7 9 17 22 cm CD WR17 Model HEM RML31 Same as the arm cuff provided with the product CD CS9 Model HEM CS24 HEM ADPTW5 ...

Страница 30: ...atteries Operating temperature humidity 50 F to 104 F 10 C to 40 C 15 to 90 RH Storage temperature humidity air pressure 4 F to 140 F 20 C to 60 C 10 to 95 RH 700 to 1060 hPa Weight Monitor Approximately 10 oz 290 g not including batteries Arm cuff Approximately 6 oz 170 g Dimensions Monitor Approximately 4 1 4 w 3 1 8 h 5 1 2 l 107 mm 79 mm 141 mm Arm cuff Approximately 5 3 4 23 1 2 air tube 29 1...

Страница 31: ...hout notice In the clinical validation study the 5th phase was used on 85 subjects for determination of diastolic blood pressure This device has not been validated for use on pregnant patients IP classification is degrees of protection provided by IEC 60529 ...

Страница 32: ...structions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures ...

Страница 33: ...urs between this Product and such other devices If such interference occurs please stop the operation of other devices or relocate this Product before using this Product or do not use this Product around the other wireless devices The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG Inc and any use of such marks by OMRON HEALTHCARE Co Ltd is under license Other tradem...

Страница 34: ...S EXPRESS OR IMPLIED INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE IMPLIED WARRANTIES AND OTHER TERMS THAT MAY BE IMPOSED BY LAW IF ANY ARE LIMITED IN DURATION TO THE PERIOD OF THE ABOVE EXPRESS WARRANTY SOME STATES DO NOT ALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS SO THE ABOVE LIMITATION MAY NOT APPLY TO YOU OMRON SHALL NOT BE LIABLE FOR LOSS OF...

Страница 35: ...hcare conform to this IEC60601 1 2 2007 standard for both immunity and emissions Nevertheless special precautions need to be observed The use of accessories and cables other than those specified by OMRON with the exception of cables sold by OMRON as replacement parts for internal components may result in increased emission or decreased immunity of the device The medical devices should not be used ...

Страница 36: ...roup 1 The OMRON BPM including AC adapter uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The OMRON BPM including AC adapter is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage ...

Страница 37: ... s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial and or hospital environment Voltage dips short interruptions and voltage variations on power supply inputlines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 5 UT 95 dip in UT for 0 5 cycle Mains power quality should be that of a typical commercial and or hospital environme...

Страница 38: ...smitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Note1 At 80 MHz and 800 MHz the higher frequency range applies Note2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection fr...

Страница 39: ...Power of Transmitter in Watt Separation distance according to frequency of transmitter in meter 150 kHz to 80 MHz d 1 2 80 MHz to 800 MHz d 1 2 800 MHz to 2 5GHz d 2 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation...

Страница 40: ...Co Ltd 53 Kunotsubo Terado cho Muko Kyoto 617 0002 JAPAN Distributed by OMRON HEALTHCARE INC 2895 Greenspoint Pkwy Hoffman Estates IL 60169 USA 1 800 634 4350 OmronHealthcare com 2021 OMRON HEALTHCARE INC Made in Japan ...

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